Oral cryotherapy for oral mucositis management in patients receiving allogeneic hematopoietic stem cell transplantation: a prospective randomized study
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To explore the best schedule of oral cryotherapy for the prevention of oral mucositis in recipients of myeloablative hematopoietic stem cell transplantation (HSCT).
A prospective randomized study was conducted to recruit allogeneic HSCT recipients, who were then randomly allocated into four arms to accept the following: oral cryotherapy during the whole course (arm A) or second half of the course (arm B) of cytotoxic agents administration, regular oral cryotherapy twice a day (arm C), or conventional oral care without cryotherapy (arm D). Status of oral mucositis was daily assessed from the first day of conditioning to the 15th day post-HSCT. A myeloablative conditioning regimen was used which was composed of busulfan, cyclophosphamide, and cytarabine.
Totally 160 cases were consecutively enrolled in this study, and 145 cases were eligible for oral mucositis assessment. Both arm A and arm B were associated with a lower incidence and short duration of severe mucositis (≥ grade 3), although no statistical difference was found between these two groups (p = 0.463, p = 0.678). The highest incidence of severe mucositis was observed in arm C. Recovery of mucositis also had a significant diversity among the 4 arms (F = 4.133, p = 0.008).
Risk and outcome of severe oral mucositis could be ameliorated by oral cryotherapy during the administration of cytotoxic agents for allogeneic HSCT patients receiving non-radiation myeloablative conditioning regimen, and a half-course schedule could acquire a comparable efficacy compared with the whole-course schedule.
KeywordsCryotherapy Oral mucositis Allogeneic hematopoietic stem cell transplantation
We sincerely acknowledge Dr. Jing Yang for her assistance with the statistical consultant in this study. We also express our gratitude to the clinical staff in the Stem Cell Transplantation Unit of the First Affiliated Hospital of Suzhou University.
This study was supported by a grant from Suzhou People’s Livelihood Science and Technology project (SYSD2016083).
Compliance with ethical standards
All participants provided informed consent, and the study was approved by the ethical institution of the First Affiliated Hospital of Soochow University (no. 2017021).
Conflict of interest
The authors declare that they have no conflict of interest.
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